Abstract

To the editor: Stamm and associates (1) address an issue of considerable clinical importance. We write to ask for clarification of their use of the term "exclusion," which has direct impact on the analysis and conclusions of their study.

Randomization in clinical trials is a method to reduce bias when assigning patients to different treatment regimens (2). To preserve this benefit, strict attention must be paid to preserving the integrity of the groups after randomization. Ideally, subjects not eligible for the protocol are excluded before randomization; this is not always possible in practice. In this report some of the inclusion